Automatic region of interest selection for imaging-based urine analyzers

Abstract

Methods and systems for automatically selecting a region of interest in an image captured by an optical inspection device are disclosed herein. A method includes analyzing pixels within an image of a liquid sample carrier to determine a location of an indicator within the image; determining a read region position of a read region of the liquid sample carrier within the image based on the position of the indicator determined by analyzing the pixels within the image; and analyzing pixels within the image depicting the read area to determine the presence and / or absence of a predetermined analyte in the liquid sample disposed on the liquid sample carrier. The liquid sample carrier can be a reagent strip or a kit. The indicator may be a reference, a symbol, a colored region, or a material configured to appear different when exposed to an electromagnetic spectrum of a particular wavelength.

Description

[0001] FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT Not Applicable.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims priority to U.S. Application Serial No. 63 / 502,239, filed May 15, 2023, the entirety of which is hereby incorporated by reference herein. BACKGROUND

[0003] One convenient way to screen for and monitor patients for diseases is to perform point-of-care tests using bodily fluids such as blood, urine, saliva, sputum, and the like. Of these bodily fluids, urine is a particularly important bodily fluid because it contains major physiological and pathological information. Moreover, samples can be easily collected making urine convenient for taking multiple samples, performing test screenings, monitoring diseases, and drawing conclusive inferences. For example, analyzing a patient’s urine sample can allow for drawing preliminary conclusions in diagnosing, for example, urinary tract infections, diabetes, and kidney and liver diseases.

[0004] Typically, analyzing a urine sample involves dipping a strip of a dry reagent pad into the sample. Such tests are often colorimetric tests; that is, the reagent pad changes color based on the concentration of a particular analyte present in the sample. These color changes are often visually inspected by a human expert. However, visual inspection performed by a human can be prone to errors, subjective, and time-consuming. To overcome these limitations, automated urine analysis instruments can be used. One such instrument can include a camera sensor, a processor, and an illumination source, enabling the instrument to extract clinical information from the color change of the reagent pad. SUMMARY

[0005] In one aspect, the present disclosure relates to a method comprising: analyzing, by a processor, pixels within an image of a liquid sample carrier to determine a location of an indicator within the image, the liquid sample carrier having a liquid sample disposed thereon; determining, by the processor, a read area location of a read area of the liquid sample carrier within the image based at least in part on the location of the indicator determined by analyzing the pixels within the image; and analyzing, by the processor, pixels within the image that depict the read area to determine a presence and / or absence of a predetermined analyte in the liquid sample.

[0006] In another aspect, the present disclosure is directed to an optical inspection device comprising: a housing having an interior containing an inspection location; an indicator located within the inspection location; a light source configured to illuminate the inspection location within the housing; a tray assembly configured to receive a liquid sample carrier, the tray assembly being insertable into the inspection location of the housing; a sensor configured to capture an image of the inspection location of the housing including the indicator; and a controller having a processor operable to execute processor executable code that, when executed by the processor, causes the processor to: analyze pixels within the image captured by the sensor to determine a location of the indicator within the image; determine a read region location of a read region within the image based at least in part on the location of the indicator determined by analyzing the pixels within the image; and analyze pixels within the read region of the image to determine a presence and / or absence of a predetermined analyte.

[0007] In another aspect, the present disclosure is directed to an optical inspection device comprising: a housing having an interior containing an inspection location; an indicator located within the inspection location; a light source configured to illuminate the inspection location within the housing; a tray assembly configured to receive a liquid sample carrier, the tray assembly being insertable into the inspection location of the housing; a sensor configured to capture an image of the inspection location of the housing including the indicator; and a controller having a processor operable to execute processor executable code that, when executed by the processor, causes the processor to: analyze pixels within the image captured by the sensor to determine a location of the indicator within the image; determine a read region location of a read region within the image based at least in part on the location of the indicator determined by analyzing the pixels within the image; and analyze pixels within the read region of the image to determine a presence and / or absence of a predetermined analyte. BRIEF DESCRIPTION OF DRAWINGS

[0008] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one or more implementations described herein and, together with the description, explain these implementations. The drawings in this figure are not intended to be drawn to scale, and some features and some views can be exaggerated for clarity and simplicity. Every component in every drawing can not be labeled. The same reference numbers in the figures can represent and refer to the same or similar elements or functions. In the drawings: Figure 1 is a perspective view of an optical inspection device configured in accordance with the present disclosure that can be used to perform various tests on a bodily fluid sample; Figure 2 is Figure 1Block diagram of the circuit of the optical inspection apparatus shown in Figure 3 is for use with Figure 1 Perspective view of a reagent strip for inspection by the optical inspection apparatus shown in Figure 4 is for use with Figure 1 Perspective view of a reagent cartridge for inspection by the optical inspection apparatus shown in Figure 5 is for use with Figure 1 Exploded perspective view of a tray assembly constructed in accordance with the present disclosure for use with the optical inspection apparatus shown in, wherein the insert is shown positioned in the support tray with the first surface facing upward so that a reagent strip can be held by the insert; Figure 6 is for use with Figure 1 Exploded perspective view of a tray assembly constructed in accordance with the present disclosure for use with the optical inspection apparatus shown in, wherein the insert is shown positioned in the support tray with the second surface facing upward so that a reagent cartridge can be held by the insert; Figure 7 is Figure 5 Perspective view of a portion of the tray assembly shown in, wherein the insert is shown positioned in the support tray with the first surface facing upward; Figure 8 is Figure 6 Perspective view of a portion of the support tray of the assembly shown in; Figure 9 is Figure 5 Perspective view of the insert of the tray assembly shown in; Figure 10 is for use with Figure 1 Perspective view of another tray assembly constructed in accordance with the present disclosure for use with the optical inspection apparatus shown in, wherein the insert is shown positioned in the support tray in a first position so that a reagent strip can be held by the insert; Figure 11 is Figure 10 Another perspective view of the tray assembly shown in, wherein the insert is shown positioned in the support tray in a second position so that a reagent cartridge can be held by the support tray; Figure 12 is for use with Figure 1 Perspective view of another tray assembly constructed in accordance with the present disclosure for use with the optical inspection apparatus shown in, wherein the insert is shown positioned in the support tray in a first position so that a reagent strip can be held by the insert; Figure 13 is Figure 12 Another perspective view of the tray assembly shown in, wherein the insert is shown positioned in the support tray so that a reagent cartridge can be held by the support tray; Figure 14 is a process flow diagram for a method of optically inspecting a liquid sample disposed on a liquid sample carrier; Figure 15 is an exemplary image captured by the optical inspection apparatus shown in Figure 1 Figure 16 is another exemplary screenshot of an image captured by the optical inspection apparatus shown in Figure 1 Figure 17 is another exemplary screenshot of an image captured by the optical inspection apparatus shown in Figure 1 Figure 18 is another exemplary screenshot of an image captured by the optical inspection apparatus shown in Figure 1 Figure 19 is an exemplary screenshot of a one-dimensional gradient representation of the image shown in Figure 15 Figure 20 is an exemplary screenshot of a template gradient representation for association with the one-dimensional gradient representation shown in Figure 19 Figure 21 is an exemplary screenshot of a magnified and inverted portion of the one-dimensional gradient representation shown in Figure 19 DETAILED DESCRIPTION

[0009] Before any embodiments of the present inventive concepts are explained in detail, it is to be understood that the inventive concepts are not limited in their application to the details of construction and the arrangements of components set forth in the following description or illustrated in the following drawings. The inventive concepts are capable of other embodiments or of being practiced or carried out in various ways. As such, the language used herein is intended to be broadly construed and interpreted, and the embodiments are intended to be exemplary rather than exhaustive. Moreover, it should be appreciated that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.

[0010] ​​​​​​​The headings are for convenience only and should not be construed as limiting the invention in any way. Embodiments shown under any heading or in any part of this disclosure may be combined with embodiments shown under the same or any other heading or in other parts of this disclosure. Unless otherwise stated herein or the context clearly contradicts it, the invention covers any combination of the elements described herein in all possible variations.

[0011] Unless the context requires otherwise, singular terms shall include plural terms, and plural terms shall include singular forms, except that the term “multiple” as used herein does not include singular forms.

[0012] All patents or published patent applications cited in any part of this application are expressly incorporated herein by reference in their entirety, to the extent that each individual patent or publication is specifically and individually indicated for inclusion by reference.

[0013] In view of this disclosure, all components, systems, kits, and / or methods disclosed herein can be manufactured and performed without excessive experimentation. Where the method claims do not expressly specify that the steps should be limited to a particular order in the claims or specification, it is by no means intended to infer the order from any aspect. This applies to any possible unexplained basis, including logical questions regarding the arrangement of steps or the flow of operations, literal meanings derived from grammatical structure or punctuation, or the number or type of embodiments described in the specification.

[0014] As used in accordance with this disclosure, unless otherwise stated, the following terms shall be understood to have the following meanings: When used in conjunction with the term "comprising" in the claims and / or description, the terms "a," "an," or "one" may mean "a," but are also consistent with the meanings of "one or more," "at least one," and "one or more." The term "a plurality of" means "two or more."

[0015] The term “at least one” will be understood to include one and any quantity more than one. Additionally, the term “at least one of X, Y, and Z” will be understood to include X alone, Y alone, and Z alone, as well as any combination of X, Y, and Z.

[0016] The use of ordinal terms (i.e., “first,” “second,” “third,” “fourth,” etc.) is for the purpose of distinguishing two or more items only and is not intended to imply any order or sequence or importance of one item relative to another, or any order of addition, for example.

[0017] The term “or” is used in claims to mean inclusive “and / or”, unless it is explicitly stated that only alternatives are referred to, or unless the alternatives are mutually exclusive.

[0018] Reference is now made to the drawings, and in particular to Figure 1 which shows an optical inspection apparatus 100 (hereinafter "apparatus 100") constructed in accordance with the present disclosure. In some embodiments, the apparatus 100 can include an optical reflectance or absorbance based reader 203 (hereinafter "reader 203") (shown in Figure 2 ) for optically inspecting a liquid sample, such as a bodily fluid sample, placed on a liquid sample carrier, such as a reagent strip 300 (shown in Figure 3 ) or a cartridge 312 (shown in Figure 4 ). In one version, the reader 203 is a reflectance spectrometer.

[0019] The apparatus 100 can include a housing 104 having an interior containing an inspection location, the housing 104 having an opening 108 formed therein into which a tray assembly 400 (shown in Figures 5-6 ) can enter, a door 112 in the opening 108 that can open when the tray assembly 400 extends outwardly from the opening 108, a touch screen display 116 for user input and to display various messages (e.g., test results) to the user related to the operation of the apparatus 100, and an activation button 120. The inspection location can be a location in which the reagent strip 300 and / or cartridge 312 will be positioned within the housing 104.

[0020] As discussed further below, the tray assembly 400 can be adapted to receive a liquid sample carrier, such as the reagent strip 300 or cartridge 312. A user can then press one of the touch screen display 116 and the activation button 120 to cause a controller 202 (shown in Figure 2 ) (which can be contained within the housing 104 or remote from the apparatus 100) to move the tray assembly 400 inwardly toward the inspection location to perform the optical inspection.

[0021] In use, a user can prepare a liquid sample carrier, such as the reagent strip 300 or cartridge 312, for optical inspection by placing a bodily fluid sample on the liquid sample carrier and placing the liquid sample carrier into the tray assembly 400. The user can then press one of the touch screen display 116 and / or the activation button 120 to cause the controller 202 to retract the tray assembly 400 inwardly so that a light source 204 (shown in Figure 2 ) disposed within the housing 104 of the apparatus 100 can illuminate the inspection location (including a reading area of the liquid sample carrier) within the housing 104 and a sensor 206 (shown in Figure 2(As shown in the diagram) It can capture one or more images of an illuminated liquid sample carrier. In some embodiments, sensor 206 can capture a time-based image sequence of the illuminated liquid sample carrier. As further discussed below, the reading area of ​​the liquid sample carrier may be the reagent pad 308 of the reagent strip 300 ( Figure 3 (as shown in the image) or reagent pad area 310 ( Figure 3 (as shown in the image), or window 324 of kit 312 ( Figure 4 (As shown in the image).

[0022] Now for reference Figure 2 The diagram illustrates a circuit 200 constructed according to the present disclosure. The circuit 200 may be contained within a housing 104 of device 100 and may include a controller 202 and a reader 203, the reader 203 including a light source 204 and a sensor 206. The light source 204 may be configured to illuminate an inspection location within the housing 104. The sensor 206 may be configured to capture one or more images of the inspection location of the housing 104, as discussed in more detail below. Exemplary sensors 206 include: charge-coupled device sensors; complementary metal-oxide-semiconductor sensors; ultraviolet sensors; infrared sensors; and combinations thereof. The light source 204 may be implemented as a means of emitting photons when actuated by processor 212. Exemplary light sources 204 include: incandescent bulbs; fluorescent lamps; light-emitting diodes; halogen lamps; neon lamps; gas discharge lamps; and combinations thereof.

[0023] In some implementations, the controller 202 may include, but is not limited to, the following: personal computer, cellular phone, smartphone, networked TV, tablet computer, laptop computer, desktop computer, networked handheld device, server, digital video recorder, wearable networked device, virtual reality / augmented reality device, etc.

[0024] In some embodiments, the controller 202 can include one or more input devices 208 (hereinafter “input device 208”), one or more output devices 210 (hereinafter “output device 210”), one or more processors 212 (hereinafter “processor 212”), one or more communication devices 216 (hereinafter “communication device 216”) capable of interfacing with a communication network 220, and one or more non-transitory computer-readable media 224 (hereinafter “controller memory 224”) storing processor-executable code and / or one or more software applications 228 (hereinafter “software application 228”) and databases 232, e.g., including a web browser capable of accessing websites and / or transmitting information and / or data over a wireless or wired network, e.g., the communication network 220. The input device 208, output device 210, processor 212, communication device 216, and controller memory 224 can be connected via a path 236, e.g., a data bus, allowing communication between the components of the controller 202.

[0025] In some embodiments, the processor 212 can include one or more processors 212 that work together or independently to read and / or execute processor-executable code and / or data, e.g., processor-executable code and / or data stored in the controller memory 224. The processor 212 is capable of creating, manipulating, retrieving, altering, and / or storing data structures in the controller memory 224. The processor 212 executing the software applications 228 stored in the controller memory 224 can become a special purpose machine adapted to perform various actions, operations, analyses, etc. in accordance with the systems and methods described herein and illustrated in the drawings. Each element of the controller 202 can be partially or entirely network-based or cloud-based and can or can not be located in a single physical location.

[0026] For example, exemplary embodiments of the processor 212 can include, but are not limited to, a digital signal processor (DSP), a central processing unit (CPU), a field- programmable gate array (FPGA), a microprocessor, a multi-core processor, an application- specific integrated circuit (ASIC), combinations thereof, and the like. The processor 212 is capable of communicating with the controller memory 224 via the path 236. The processor 212 is capable of communicating with the input device 208 and / or the output device 210 via the path 236.

[0027] For example, when executed by the processor 212, the software applications 228 can cause the controller 202 to perform the method 800 (shown in FIG. Figure 14 and / or perform actions such as communicating with or controlling one or more components of the device 100, the controller 202, and / or the communication network 220.

[0028] In some embodiments, the controller memory 224 can be located in the same physical location as the controller 202, and / or one or more controller memories 224 can be located remotely from the controller 202. For example, the controller memory 224 can be located remotely from the controller 202 and in communication with the processor 212 via the communication network 220. Additionally, when more than one controller memory 224 is used, a first controller memory 224 can be located in the same physical location as the processor 212, and one or more additional controller memories 224 can be located physically remote from the processor 212. Additionally, the controller memory 224 can be implemented as a “cloud” non-transitory processor-readable storage memory (i.e., one or more of the controller memories 224 can be accessed, in part or in whole, based on or using the communication network 220).

[0029] In one embodiment, the database 232 can be a time series database, a relational database, or a non-relational database. Examples of such databases include DB2®, Microsoft® Access, Microsoft® SQL Server, Oracle®, MySQL, PostgreSQL, MongoDB, Apache Cassandra, InfluxDB, Prometheus, Redis, Elasticsearch, TimescaleDB, and the like. It should be understood that these examples are provided for illustrative purposes only and should not be construed as limiting the presently disclosed inventive concepts. The database 232 can be centralized or distributed across multiple systems.

[0030] The input device 208 is capable of receiving input of information from a user, another computer, and / or the processor 212 and transmitting that information to other components of the controller 202 and / or the communication network 220. For example, the input device 208 can include, but is not limited to, the start button 120, the touchscreen display 116, a keyboard, a touchscreen, a mouse, a trackball, a microphone, a video camera, a fingerprint reader, an infrared port, a slide-out keyboard, a flip-out keyboard, a cell phone, a PDA, a remote control, a fax machine, a wearable communication device, a network interface, combinations thereof, and the like.

[0031] The output device 210 is capable of outputting information in a form perceptible to a user, another controller, and / or the processor 212. For example, embodiments of the output device 210 can include, but are not limited to, for example, the touchscreen display 116, a computer monitor, a screen, a touchscreen, a speaker, a website, a television, a smartphone, a PDA, a cell phone, a facsimile machine, a printer, a laptop, a haptic feedback generator, a network interface, combinations thereof, and the like. It is to be understood that, in some example embodiments, the input device 208 and the output device 210 can be implemented as a single device, such as the touchscreen display 116, or a touchscreen of a computer, tablet, or smartphone. It is also to be understood that, as used herein, the term "user" is not limited to a human and can include, for example, a computer, a server, a website, a processor, a network interface, a user terminal, a virtual computer, combinations thereof, and the like.

[0032] Reference is now made to Figure 3 which shows a perspective view of a reagent strip 300 constructed in accordance with the present disclosure. The reagent strip 300 can have a thin, non-reactive substrate 304 (hereinafter "substrate 304") on which reagent pads 308 are affixed in a reagent pad region 310. Each reagent pad 308 can be composed of a relatively absorbent material (e.g., cellulose-based materials such as paper, cotton, and nitrocellulose membranes; glass fibers; and / or polyesters) impregnated with a respective (i.e., different) reagent, each reagent and reagent pad 308 being associated with a particular test to be performed based on the reagents used. When each reagent pad 308 is contacted with a body fluid sample, the reagent pad 308 can change color over a period of time, depending on the characteristics of the reagents used and the body fluid sample.

[0033] As described further below, in some embodiments, each reagent pad 308 is a separate reading region of the reagent strip 300 for purposes of Figure 1 optical inspection by the processor 212 of the apparatus 100 shown in Figure 1 In some embodiments, the upper surface 311 of the substrate 304 of the reagent strip 300 has one or more characters or symbols 910 (hereinafter "symbols 910") printed, engraved, or otherwise disposed thereon for purposes of Figure 15 optical inspection by the processor 212 of the apparatus 100 shown in

[0034] Reference is now made to Figure 4The diagram shows a perspective view of a kit 312 constructed according to the present disclosure. For example, kit 312 may be a disposable, single-use kit for performing pregnancy tests in a routine manner. Kit 312 may have an opening or hole 316 (hereinafter “hole 316”) formed in an upper surface 320 into which a bodily fluid sample is placed. The interior of kit 312 may have a reagent strip 300 that reacts with the bodily fluid sample placed in the hole 316. Depending on the test results, the reagent strip 300 may change color (e.g., colored stripes may appear), which can be determined by viewing the reagent strip 300 through a window 324 formed in the upper surface 320 of kit 312. Kit 312 may include a first portion 328 and a second portion 332, the first portion 328 having a curved end wall 336, and the first portion 328 and the second portion 332 being separated by recesses 340a and 340b.

[0035] As further described below, window 324 may be a reading area of ​​reagent kit 312 for use in supplying... Figure 1 The processor 212 of the device 100 shown is for optical inspection purposes. In some embodiments, the upper surface 320 of the reagent kit 312 may have one or more characters or symbols 916 (hereinafter referred to as "symbols 916") printed, engraved, or otherwise disposed thereon. Figure 16 (As shown in the image). Alternatively or additionally, such as Figure 17 As shown, the upper surface 320 of the reagent kit 312 may have a luminescent material 918 disposed thereon (i.e., a material that appears different when exposed to a specific wavelength of electromagnetic spectrum). Alternatively or additionally, as Figure 18 As shown, the upper surface 320 of the reagent kit 312 may have a colored area 920 with a predetermined color value disposed thereon. As explained below, the processor 212 of the device 100 may use one or more of the symbol 916, the luminescent material 918, and the colored area 920 as indicators to determine the location of the reading area of ​​the reagent kit 312.

[0036] While the systems and methods described herein are described as relating to the performance of fluid analysis tests, and particularly urine analysis tests, those skilled in the art will understand that the benefits and advantages described herein apply to the performance of any type of optical fluid analysis test. When performing urine analysis tests, these may include, for example, tests for white blood cells in urine, tests for urine pH, tests for blood in urine, etc.

[0037] Now for reference Figure 5 and Figure 6 The diagram shows the method for use with Figure 1The diagram shows a perspective view of a tray assembly 400 constructed according to the present disclosure, used in conjunction with the device 100 shown. As described above, the tray assembly 400 may be adapted to receive a reagent strip 300 or a reagent kit 312; that is, the tray assembly 400 may include a support tray 404 and an insert 408 fitted into the support tray 404, wherein the insert 408 is provided with a first surface 412 adapted to hold the reagent strip 300. Figure 5 (as shown in the diagram) and a second surface 416 suitable for retaining the kit 312 ( Figure 6 (As shown in the diagram). The first surface 412 and the second surface 416 may be disposed on opposite sides of the insert 408. Figure 5 In the diagram, the tray assembly 400 is shown with the first surface 412 of the insert 408 facing upwards, such that the reagent strip 300 can be held in the support tray 404 by the insert 408, and... Figure 6 In the diagram, the tray assembly 400 is shown with the second surface 416 facing upwards, allowing the reagent strip 312 to be held in the support tray 404 via the insert 408. Thus, the user can choose to insert the insert 408 into the support tray 404 with either the first surface 412 or the second surface 416 facing upwards, depending on whether the user wishes to optically examine the reagent strip 300 or the reagent strip 312.

[0038] The first surface 412 of the insert 408 may have an elongated channel 420 sized to accommodate the reagent strip 300. The elongated channel 420 may be recessed relative to the remainder of the first surface 412 such that when the reagent strip 300 is held by the insert 408, the substrate 304 of the reagent strip 300 may be flush with the remainder of the first surface 412 (i.e., the unrecessed portion). The first surface 412 of the insert 408 may also have an end wall 424 that closes the elongated channel 420 at one end of the insert 408. The top surface 428 of the end wall 424 (hereinafter referred to as "reference 428") may be white (or another suitable color) and designed to be captured in an image (e.g., having a different color from the background) and detected by the processor 212. For example, Figure 1 The processor 212 of the device 100 shown can use end wall 424 to determine whether the test strip 300 is correctly abutting end wall 424 during the examination procedure. As further described below, the processor 212 of the device 100 can also use reference 428 as an indicator to determine the location of the reading area of ​​the test strip 300. The elongated channel 420 may have an open end 426 such that the test strip 300 can be slidably inserted into the insert 408. Reference Figure 6The second surface 416 of the insert 408 can have a recess 430 shaped to receive the first portion 328 of the cartridge 312. The end wall 432 of the recess 430 of the second surface 416 of the insert 408 can be curved to match the curved end wall 336 of the first portion 328 of the cartridge 312, thereby ensuring that the user properly orients the cartridge 312 within the insert 408. The insert 408 can include a ridge or protrusion 434a, 434b at the open end 436 of the recess 430 that is respectively received in the recess 340a, 340b of the cartridge 312 to prevent the cartridge 312 from sliding out of the insert 408. Alternatively, the protrusions 434a, 434b can be provided on the cartridge 312 and the recesses 340a, 340b provided in the insert 408. When the cartridge 312 is properly positioned within the insert 408 such that only the first portion 328 is in the recess 430, the second portion 332 of the cartridge 312 can extend outward beyond the open end 436 of the recess 430. The second portion 332 of the cartridge 312 can be separated from the first portion 328 of the cartridge 312 by the recess 340a, 340b of the cartridge 312.

[0039] As is apparent from the above description, Figure 6 The second portion 332 of the cartridge 312 can be shorter than the first portion 328 of the cartridge 312 to further ensure that the user properly orients the cartridge 312 within the insert 408, as is apparent from the above description. Additionally, the protrusions 434a, 434b of the recess 430 can be provided in slightly different sizes or shapes, and the recesses 340a, 340b of the cartridge 312 can also be provided in slightly different sizes or shapes that match the protrusions 434a, 434b to prevent the cartridge 312 from being inserted upside down into the insert 408.

[0040] The first surface 412 and the second surface 416 of the insert 408 can face in opposite directions, and the insert 408 can further include a first opposing end 438 and a second opposing end 440 that connect the first surface 412 and the second surface 416, and a first opposing side 442 and a second opposing side 444 that connect the first surface 412 and the second surface 416 and extend between the first opposing end 438 and the second opposing end 440.

[0041] The support tray 404 may further include a first opposing end 448 and a second opposing end 452, a top surface 456 extending between the first opposing end 448 and the second opposing end 452, and a compartment 460 extending from the first end 448 toward a first end wall 464 for receiving the insert 408. The compartment 460 may include a first end wall 464 that mates with the second end 440 of the insert 408, and opposing first side walls 468 and second side walls 472 that extend from the first end wall 464 toward the first end 448 of the support tray 404 and mate with the first opposing side 442 and the second opposing side 444 of the insert 408.

[0042] The first and second opposing ends 438, 440 of the insert 408 have different shapes to ensure that the user will correctly orient the insert 408 within the support tray 404 during use. Figures 5-7 and Figure 9 In the embodiment shown, the first end 438 of the insert 408 is rectangular in shape, and the second end 440 of the insert 408 is curved.

[0043] The top surface 456 of the support tray 404 may include an elongated channel 476 extending from the second end 452 of the support tray 404 toward the second end wall 478, and a white calibration strip (not shown) may be received in the elongated channel 476 of the support tray 404. This white calibration strip may be used by the device 100 to determine white balance, so that any colorimetric analysis performed using the device 100 can be properly calibrated. The elongated channel 476 may be recessed relative to the top surface 456. The top surface 456 of the support tray 404 may also include an inclined surface 480 extending from the center of the first end wall 464 of the compartment 460 toward the second end wall 478 of the elongated channel 476, the inclined surface 480 sloping downward toward the compartment 460. The first surface 412 and the second surface 416 of the insert 408 may include valleys or recesses 484 that correspond to the inclined surface 480 of the support tray 404 when the insert 408 is located within the compartment 460. The inclined surface 480 facilitates proper optical inspection of the reagent strip 300 and the kit 312 by providing guidance for proper alignment and positioning of the insert 408 within the support tray 404.

[0044] like Figures 5-8 As shown, the sidewalls 468, 472 of the compartment 460 of the support tray 404 may include cutouts 488 to allow gripping of the sides 442, 444 of the insert 408 when it is positioned within the compartment 460. The support tray 404 may also include an elongated guide 492 extending from the compartment 460 toward a second end 452 of the support tray 404, and as shown... Figures 5-7 and Figure 9As shown in FIG. 4, the first surface 412 and the second surface 416 of the insert 408 can include elongated guides 496 that correspond to the elongated guides 492 of the support tray 404 when the insert 408 is positioned within the compartment 460. The elongated guides 492, 496 can be slots that receive wheels (not shown) mounted within the device 100 that help to smoothly guide, extend, and retract the tray assembly 400 relative to the housing 104 of the device 100. The insert 408 also defines a recess 500 in the elongated guides 496 of the first surface 412 and the second surface 416 that prevents excess bodily fluid from flowing off of the insert 408 and down the guides 492 of the support tray 404 (and, thus, into the device 100). Accordingly, the recess 500 retains excess bodily fluid spillage and helps to prevent contamination of the device 100 with excess bodily fluid contained on the insert 408, the reagent strip 300, or the reagent cartridge 312. Figure 1 As shown in FIG. 4, the first surface 412 and the second surface 416 of the insert 408 can include elongated guides 496 that correspond to the elongated guides 492 of the support tray 404 when the insert 408 is positioned within the compartment 460. The elongated guides 492, 496 can be slots that receive wheels (not shown) mounted within the device 100 that help to smoothly guide, extend, and retract the tray assembly 400 relative to the housing 104 of the device 100. The insert 408 also defines a recess 500 in the elongated guides 496 of the first surface 412 and the second surface 416 that prevents excess bodily fluid from flowing off of the insert 408 and down the guides 492 of the support tray 404 (and, thus, into the device 100). Accordingly, the recess 500 retains excess bodily fluid spillage and helps to prevent contamination of the device 100 with excess bodily fluid contained on the insert 408, the reagent strip 300, or the reagent cartridge 312.

[0045] As shown in FIG. 4, the first surface 412 and the second surface 416 of the insert 408 can include elongated guides 496 that correspond to the elongated guides 492 of the support tray 404 when the insert 408 is positioned within the compartment 460. The elongated guides 492, 496 can be slots that receive wheels (not shown) mounted within the device 100 that help to smoothly guide, extend, and retract the tray assembly 400 relative to the housing 104 of the device 100. The insert 408 also defines a recess 500 in the elongated guides 496 of the first surface 412 and the second surface 416 that prevents excess bodily fluid from flowing off of the insert 408 and down the guides 492 of the support tray 404 (and, thus, into the device 100). Accordingly, the recess 500 retains excess bodily fluid spillage and helps to prevent contamination of the device 100 with excess bodily fluid contained on the insert 408, the reagent strip 300, or the reagent cartridge 312. Figures 5-6 Figure 8 As shown in FIG. 4, the first surface 412 and the second surface 416 of the insert 408 can include elongated guides 496 that correspond to the elongated guides 492 of the support tray 404 when the insert 408 is positioned within the compartment 460. The elongated guides 492, 496 can be slots that receive wheels (not shown) mounted within the device 100 that help to smoothly guide, extend, and retract the tray assembly 400 relative to the housing 104 of the device 100. The insert 408 also defines a recess 500 in the elongated guides 496 of the first surface 412 and the second surface 416 that prevents excess bodily fluid from flowing off of the insert 408 and down the guides 492 of the support tray 404 (and, thus, into the device 100). Accordingly, the recess 500 retains excess bodily fluid spillage and helps to prevent contamination of the device 100 with excess bodily fluid contained on the insert 408, the reagent strip 300, or the reagent cartridge 312.

[0046] As shown in FIG. 4, the first surface 412 and the second surface 416 of the insert 408 can include elongated guides 496 that correspond to the elongated guides 492 of the support tray 404 when the insert 408 is positioned within the compartment 460. The elongated guides 492, 496 can be slots that receive wheels (not shown) mounted within the device 100 that help to smoothly guide, extend, and retract the tray assembly 400 relative to the housing 104 of the device 100. The insert 408 also defines a recess 500 in the elongated guides 496 of the first surface 412 and the second surface 416 that prevents excess bodily fluid from flowing off of the insert 408 and down the guides 492 of the support tray 404 (and, thus, into the device 100). Accordingly, the recess 500 retains excess bodily fluid spillage and helps to prevent contamination of the device 100 with excess bodily fluid contained on the insert 408, the reagent strip 300, or the reagent cartridge 312. Figures 5-6 Figure 1 As shown in FIG. 4, the first surface 412 and the second surface 416 of the insert 408 can include elongated guides 496 that correspond to the elongated guides 492 of the support tray 404 when the insert 408 is positioned within the compartment 460. The elongated guides 492, 496 can be slots that receive wheels (not shown) mounted within the device 100 that help to smoothly guide, extend, and retract the tray assembly 400 relative to the housing 104 of the device 100. The insert 408 also defines a recess 500 in the elongated guides 496 of the first surface 412 and the second surface 416 that prevents excess bodily fluid from flowing off of the insert 408 and down the guides 492 of the support tray 404 (and, thus, into the device 100). Accordingly, the recess 500 retains excess bodily fluid spillage and helps to prevent contamination of the device 100 with excess bodily fluid contained on the insert 408, the reagent strip 300, or the reagent cartridge 312.

[0047] As shown in FIG. 4, the first surface 412 and the second surface 416 of the insert 408 can include elongated guides 496 that correspond to the elongated guides 492 of the support tray 404 when the insert 408 is positioned within the compartment 460. The elongated guides 492, 496 can be slots that receive wheels (not shown) mounted within the device 100 that help to smoothly guide, extend, and retract the tray assembly 400 relative to the housing 104 of the device 100. The insert 408 also defines a recess 500 in the elongated guides 496 of the first surface 412 and the second surface 416 that prevents excess bodily fluid from flowing off of the insert 408 and down the guides 492 of the support tray 404 (and, thus, into the device 100). Accordingly, the recess 500 retains excess bodily fluid spillage and helps to prevent contamination of the device 100 with excess bodily fluid contained on the insert 408, the reagent strip 300, or the reagent cartridge 312. Figure 5 Figure 1 ​​​The door 112 of the device 100 shown in FIG. 1, and the door 112 can be closed when the support tray 404 is retracted into the housing 104 of the device 100. Closing the door 112 during the detection phase can prevent ambient light from entering into the housing 104 of the device 100 and causing poor or inaccurate results. In Figure 7 In the embodiment shown in FIG. 4, the cam surface 520 can extend from the first side wall 468 of the support tray 404.

[0048] During use, the insert 408 of the tray assembly 400 can be removed from the support tray 404 and can be flipped and reinserted into the support tray 404, depending on which of the reagent strip 300 and the reagent cartridge 312 is to be used with the tray assembly 400. Since the reagent strip 300 and the reagent cartridge 312 do not directly contact the support tray 404, but are instead supported by the insert 408, the support tray 404 is less likely to be contaminated by excess bodily fluids from the reagent strip 300 and the reagent cartridge 312. Conversely, if necessary, the insert 408 can be removed from the support tray 404 and cleaned of excess bodily fluids. Additionally, the support tray 404 can be easily cleaned when the insert 408 is removed.

[0049] Figures 10-11 Another exemplary embodiment of a tray assembly 600 constructed in accordance with the present disclosure is shown for use with the device 100 of Figure 1 The tray assembly 600 can include a support tray 604 and a received insert 608 for movement within the support tray 604. For example, the insert 608 can be moved between a first position (shown in Figure 10 ) and a second position (shown in Figure 11 ). In Figure 10 , the insert 608 is shown in the first position such that a reagent strip 300 can be inserted into the insert 608 and used with the tray assembly 600. The insert 608 can have an elongated channel 612 (similar to the elongated channel 420 shown in Figure 5 ) sized to accommodate the reagent strip 300, an end wall 616 closing the elongated channel 612 at one end of the insert 608, and an open end 618 such that the reagent strip 300 can be slidably inserted into the insert 608. In Figure 11 , the insert 608 is shown in the second position to allow a reagent cartridge 312 to be inserted into the support tray 604.

[0050] The support tray 604 can include a first opposing end 620 and a second opposing end 624 and a top surface 628 extending between the first opposing end 620 and the second opposing end 624 and having a compartment 632 extending from an open end 636 at the first end 620 of the support tray 604 to an end wall 640 closer to the second end 624 of the support tray 604. The insert 608 can be movably supported within the compartment 632 of the support tray 604 and movable between a first position adjacent the open end 636 of the compartment 632 (as shown in Figure 10 ) and a second position adjacent the end wall 640 of the compartment 632 (as shown in Figure 11 ). When the insert 608 is in the second position as shown in Figure 11 , the cartridge 312 can be inserted into the compartment 632 between the open end 636 of the compartment 632 and the insert 608. As discussed further below, the cartridge 312 can be secured in the compartment 632 by a plurality of upwardly extending positioning members 664. The open end 618 of the insert 608 can abut the cartridge 312.

[0051] In the exemplary embodiment of Figures 10-11 , the insert 608 can be slidably movable between the first and second positions within the compartment 632 of the support tray 604. As shown, the side walls 648, 652 of the compartment 632 of the support tray 604 can include channels 656 and the sides of the insert 608 can include rails 660 received in the channels 656 for guiding the sliding movement of the insert 608 within the compartment 632. In the embodiment shown in Figures 10-11 , the insert 608 cannot be removed from the support tray 604. However, in some embodiments, the insert 608 can be slidably removed from the support tray 604.

[0052] The open end 636 at the first end 620 of the support tray 604 can have positioning members 664, for example, in the form of pins. When the reagent strip 300 or cartridge 312 is placed within the support tray 604, the positioning members 664 can be located within a plurality of apertures or holes (not shown) formed in the bottom surface of the reagent strip 300 or cartridge 312 so that the positioning members 664 can prevent the reagent strip 300 or cartridge 312 from accidentally sliding out of the compartment 632. The support tray 604 can have a regular calibration chip 668 of a particular color (e.g., white) disposed in the top surface 628 of the support tray 604 to facilitate calibration in a regular manner.

[0053] Figures 12-13 Another exemplary embodiment of a tray assembly 700 constructed in accordance with the present disclosure for use with the apparatus 100 of Figure 1 is shown in Figures 10-11the tray assembly 600 shown in FIGS. 6A-6C, but including an insert 704 that is pivotally movable between a first position and a second position shown in FIGS. 6A and 6B, respectively. When the insert 704 is in the first position, the tray assembly 700 can be adapted to receive a reagent strip 300 in an elongated channel 716 in a surface of the insert 704, as shown in FIG. 6A. The reagent strip 300 can be secured in the elongated channel 716 by a positioning member 664, as described similarly in FIGS. 4A-4C. Figure 12 When the insert 704 is in the second position, the tray assembly 700 can be adapted to receive a reagent cartridge 312 in a compartment 708 of the support tray 712. The reagent cartridge 312 can be secured in the compartment 708 by the positioning member 664, as described similarly in FIGS. 5A-5C. Figure 13 When the insert 704 is in the first position, the tray assembly 700 can be adapted to receive a reagent strip 300 in an elongated channel 716 in a surface of the insert 704, as shown in FIG. 6A. The reagent strip 300 can be secured in the elongated channel 716 by a positioning member 664, as described similarly in FIGS. 4A-4C. Figure 5 When the insert 704 is in the second position, the tray assembly 700 can be adapted to receive a reagent cartridge 312 in a compartment 708 of the support tray 712. The reagent cartridge 312 can be secured in the compartment 708 by the positioning member 664, as described similarly in FIGS. 5A-5C. Figure 11 When the insert 704 is in the second position, the tray assembly 700 can be adapted to receive a reagent cartridge 312 in a compartment 708 of the support tray 712. The reagent cartridge 312 can be secured in the compartment 708 by the positioning member 664, as described similarly in FIGS. 5A-5C.

[0054] The insert 704 can be pivotally mounted to the support tray 712 by two pins 720 that extend through sidewalls 724, 728 of the support tray 712 and through hinges 732 of the insert 704. In the embodiment shown in FIGS. 6A-6C, the insert 704 cannot be removed from the support tray 712. An anchor 736 can be secured to a floor of the compartment 708 between the hinges 732 of the insert 704 and provide an end wall 740 for the reagent strip 300 to abut and an end wall 744 for the reagent cartridge 312 to abut. Figures 12-13

[0055] Reference is now made to Figure 14 FIG. 8, which shows a method 800 for optically examining a liquid sample disposed on a liquid sample carrier, such as the reagent strip 300 and the reagent cartridge 312. In some embodiments, a software application 228 stored in the controller memory 224 of the controller 202, when executed by the processor 212 of the controller 202, can cause the processor 212 to perform one or more steps of the method 800 described herein. As shown in FIG. 8, the method 800 can include the steps of analyzing pixels within one or more images (e.g., the image 900 (FIG. 9A) shown in FIG. 9) of the liquid sample carrier (step 804), determining a read region location of a read region of the liquid sample carrier within the one or more images (step 808), and analyzing pixels within the one or more images that depict the read region to determine the presence and / or absence of a predetermined analyte in the liquid sample (step 812). This can be accomplished by, for example, comparing the color of the pixels within the read region of the one or more images or time-based image sequence to predetermined colors and / or times stored in memory that are indicative of the presence and / or absence of the predetermined analyte. Figure 14 Figures 15-18

[0056] Figure 15 ​​​An exemplary embodiment of an image 900 of a liquid sample carrier (i.e., reagent strip 300) is shown, which is captured by sensor 206 of optical inspection device 100 and stored in [the image]. Figure 2 The controller memory 224 shown is used. As described above, in some embodiments, a reference 428 is disposed on the end wall 424 of the first surface 412 of the insert 408 and is captured in the image together with the liquid sample carrier (i.e., the reagent strip 300). The processor 212 of the device 100 may be configured to analyze the image 900 to locate the reference 428, and thereby use the reference 428 as an indicator to determine the location of the reading area of ​​the reagent strip 300.

[0057] In some embodiments, during the manufacture of device 100, a known displacement 904 between reference 428 and reagent pad region 310 is measured, and data indicating the known displacement 904 and the direction to reagent pad region 310, as well as predetermined features of reagent pad 308a (e.g., leading edge 905), are stored in controller memory 224. Although each reagent pad 308 has a leading edge 905, only reagent pad 308a is labeled for clarity. The known displacement 904 may be the number of pixels from reference 428 to leading edge 905. In some embodiments, during the manufacture of device 100, multiple known displacements 908 between reference 428 and predetermined features (e.g., leading edge 905 of each reagent pad 308) are measured, and data indicating the known displacements 908 are stored in controller memory 224. In some embodiments, during the manufacture of device 100, a known displacement 909 between first reagent pad 308a and second reagent pad 308b is measured, and data indicating the known displacement 909 is stored in controller memory 224. In some embodiments, during the manufacture of device 100, a plurality of known displacements 914 between each reagent pad 308 are measured, and data indicating the known displacements 914 are stored in controller memory 224. For clarity, only one of the known displacements 908 and only one of the known displacements 914 are labeled with reference numerals. When using the known displacements 914 to position additional reagent pads 308, the dimensions (e.g., length) of the reagent pads 308 may also be stored in controller memory 224 and used to position additional reagent pads 308. For example, once the position of reference 428 is determined, the leading edge 905 of reagent pad 308a can be positioned using the known displacements 904 and orientation. Then, for example, reagent pad 308b can be positioned by adding or subtracting pixels in a known orientation using the known dimensions and known displacements 914 of reagent pad 308a. This process can be repeated to position other reagent pads 308. Once the positions of reagent pads 308a and / or 308b are determined, the position of the additional reagent pad 308 can be determined using the known displacements 904 and / or 914 and / or the dimensions of reagent pad 308.

[0058] In some embodiments, the step of analyzing the pixels within the one or more images of the reagent strip 300 (step 804) can include analyzing the pixels within the one or more images to determine the location of an indicator (e.g., the fiducial 428 or the symbol 910) within the one or more images. Analyzing the pixels within the one or more images can also include calculating a one-dimensional gradient representation 1000 (hereinafter "1D gradient 1000") of the one or more images (shown in Figure 19 FIG. 10B). Calculating the 1D gradient 1000 can include calculating the average value (e.g., intensity, multiple color values (e.g., averaging the red, green, and blue channels of a pixel to obtain a gray channel for each pixel in a row), saturation, etc.) of each pixel location along an axis 912 aligned with the reagent strip 300 and plotting the average values as shown in Figure 19 FIG. 10B.

[0059] In some embodiments, the one or more images can be converted to a color space other than RGB, such as HSV or YCbCr, or any other format suitable for processing, which are well known in the literature.

[0060] In some embodiments, the one or more images can be pre-processed by passing the one or more images through at least one filter to enhance a region of interest in the one or more images. Exemplary filters that can be used to enhance a region of interest can be a Gaussian low-pass filter, a Butterworth low-pass filter, an edge detection filter, etc., which are well known in the literature.

[0061] In some embodiments, the step of analyzing the pixels within the one or more images (step 804) can also include scanning the 1D gradient 1000 in a predetermined direction (e.g., from right to left, or from left to right as shown in Figure 19 FIG. 10B) to determine a first local maximum / minimum position 1004 of a first local maximum / minimum of the 1D gradient 1000. Since the fiducial 428 is preferably provided with a color value that contrasts with the first surface 412 of the insert 408, the location of the fiducial 428 can be determined by the first local maximum / minimum position 1004. Determining the first local maximum / minimum position 1004 can include calculating a first derivative of the 1D gradient 1000 and determining the first point at which the first derivative changes from a positive value to a negative value or from a negative value to a positive value. However, it should be appreciated that determining the first local maximum / minimum position 1004 can be accomplished in a number of different conventional ways known to those of ordinary skill in the art.

[0062] In embodiments where the known displacement 904 and the predetermined direction are stored in the controller memory 224, the step of determining a read area location of a read area of the reagent strip 300 within the one or more images (step 808) can also be defined as analyzing pixels within the one or more images to determine a read area location of the read area, where the read area is the reagent pad area 310, by applying the known displacement 904 and the predetermined direction to the first local maximum / minimum location 1004 (i.e., addition).

[0063] In embodiments where the known displacement 908 is stored in the controller memory 224, the step of determining a read area location of a read area of the reagent strip 300 within the one or more images (step 808) can also be defined as analyzing pixels within the one or more images to determine a plurality of read area locations of a plurality of read areas, where the plurality of read areas is the plurality of reagent pads 308, by applying the known displacement 908 to the first local maximum / minimum location 1004 (i.e., addition). The known displacement 908 can be a number of pixels from the location of the distance indicator within the one or more images.

[0064] In embodiments where the known displacement 909 is also stored in the controller memory 224, the step of determining a read area location of a read area of the reagent strip 300 within the one or more images (step 808) can also be defined as analyzing pixels within the one or more images to determine a first read area location of a first read area of the reagent strip 300 within the one or more images, where the first read area is the first reagent pad 308a. In such embodiments, the step of determining a read area location of a read area of the reagent strip 300 within the one or more images (step 808) can also include analyzing pixels within the one or more images to determine a second read area location of a second read area, where the second read area is the second reagent pad 308b, by applying the known displacement 909 and the predetermined direction to the determined first read area location (e.g., addition or subtraction). Thus, given that the reagent strip includes 10 reagent pads 308, the controller memory 224 can store nine known displacements 909 and one or more directions to assist the processor 212 in locating read areas of the other reagent pads 308 after locating the first read area location. The known displacement 909 can be a number of pixels from the location of the first read area within the one or more images.

[0065] In embodiments where the known displacement 909 is also stored in the controller memory 224, the step of determining the read zone position of the read zone of the reagent strip 300 within the one or more images (step 808) can further include analyzing the pixels within the one or more images to determine a plurality of additional read zone positions of a plurality of additional read zones, where the plurality of additional read zones is the plurality of reagent pads 308 (excluding the first reagent pad 308a and the second reagent pad 308b), by successively applying the known displacement 909 to the second read zone position, the third read zone position, etc. (i.e., adding).

[0066] In embodiments where the known displacement 914 is also stored in the controller memory 224, the step of determining the read zone position of the read zone of the reagent strip 300 within the one or more images (step 808) can further include determining a plurality of additional read zone positions of a plurality of additional read zones, where the plurality of additional read zones is the plurality of reagent pads 308 (excluding the first reagent pad 308a and the second reagent pad 308b), by applying a respective one of the known displacements 914 to the second read zone position, the third read zone position, etc.

[0067] In other embodiments, the step of determining the read zone position of the read zone of the reagent strip 300 within the one or more images (step 808) can further be defined as scanning the ID gradient 1000 in a predetermined direction to determine a plurality of additional local maximum / minimum positions 1008 of a plurality of additional local maximum / minimum values of the ID gradient 1000. In such embodiments, the plurality of read zone positions of the plurality of read zones can be determined from the plurality of additional local maximum / minimum positions 1008. Determining the plurality of additional local maximum / minimum positions 1008 can be based on additional constraints, such as a predetermined threshold 1012 and / or a minimum distance 1016 between each additional local maximum / minimum position 1008. In some embodiments, determining the plurality of additional local maximum / minimum positions 1008 can include calculating a first derivative of the ID gradient 1000 and determining points where the first derivative transitions from a positive value to a negative value, which correspond to the additional local maximum / minimum positions 1008. However, it should be appreciated that determining the plurality of additional local maximum / minimum positions 1008 can be accomplished in a number of different conventional ways known to those of ordinary skill in the art.

[0068] In some embodiments, the method 800 further includes determining that the determined read zone location has a uniformity value within a predetermined range. For example, in a case where a size of a portion of the ID gradient 1000 near the determined read zone location is less than a predetermined threshold (e.g., a value of 2), the read zone location can be determined to be valid. Conversely, in a case where the size of the portion of the ID gradient 1000 near the determined read zone location is greater than the predetermined threshold, the read zone location can be determined to be invalid, in which case the method 800 further includes discarding the determined read zone location and attempting to determine a valid read zone location. Such a uniformity check can be performed for each of the plurality of read zone locations.

[0069] In some embodiments, to confirm the location of the fiducial 428, the method 800 further includes storing in memory a template gradient 1100 (shown in Figure 20 FIG. 12), which represents a pure white indicator surrounded by pure black on either side; calculating a correlation factor 1204 (shown in Figure 21 FIG. 12) between a portion 1200 of the ID gradient 1000 near the fiducial 428 and the template gradient 1100, where the correlation factor 1204 is proportional to a correlation between the portion 1200 of the ID gradient 1000 near the fiducial 428 and the template gradient 1100; and determining that the correlation factor 1204 is greater than a predetermined threshold, thereby ensuring a confidence in the location of the fiducial 428 and the read zone location. In a case where the correlation factor 1204 is less than the predetermined threshold, the method 800 can include alerting a user that maintenance can be required.

[0070] In some embodiments, calculating the correlation factor includes calculating a sum of products of the template gradient 1100 and the portion 1200 of the ID gradient 1000 near the fiducial 428. However, it should be appreciated that calculating the correlation factor 1204 can be done in a number of different conventional ways known to those of ordinary skill in the art.

[0071] As described above, in some embodiments, the symbol 910 can be disposed on the upper surface 311 of the substrate 304 of the reagent strip 300. In such embodiments, the processor 212 of the software application 228 of the running device 100 can use the symbol 910 (shown in Figure 15 FIG. 11) as an indicator of the location of the read zone of the reagent strip 300, rather than the fiducial mark 428. In such embodiments, the step of analyzing pixels within the one or more images of the reagent strip 300 (step 804) can include the processor 212 analyzing the pixels within the one or more images to determine a location of the indicator (i.e., the symbol 910) within the one or more images.

[0072] Analyzing pixels within the one or more images to determine the location of symbol 910 may include performing one or more image processing-based algorithms, analyses, or operations. Non-limiting examples of the one or more image processing-based algorithms, analyses, or operations include optical character recognition algorithms, Hough transforms, connected component analysis, or machine learning or deep learning models trained on a dataset consisting of images of reagent strips 300 with symbol 910. Once the location of symbol 910 is determined, the relative position of reagent pad 308 can be determined as described above using known displacements from symbol 910 to a specific reagent pad 308, known displacements between reagent pads, and combinations thereof. The pixel colors within the one or more images depicting the reading area of ​​reagent pad 30 are then analyzed to determine the presence and / or absence of a predetermined analyte in the liquid sample. In other embodiments, machine learning or deep learning models trained on a dataset consisting of images of reagent strips 300 may be used to directly determine the location of reagent pad 308 within the one or more images.

[0073] Figures 16-18 It shows the result of Figure 1 Other exemplary embodiments of the image 900 of the liquid sample carrier (i.e., kit 312) captured by the sensor 206 of the optical inspection device 100 shown. As described above, in some embodiments, the symbol 916 may be provided on the upper surface 320 of the kit 312. Figure 16 (shown in the image), luminescent material 918 ( Figure 17 (as shown) or color area 920 ( Figure 18 (As shown in the image).

[0074] In some embodiments, during the manufacture of device 100, multiple known displacements 922 between one or more of the symbols 916 and window 324 are measured, and data indicating the known displacements 922 are stored in controller memory 224. In some embodiments, during the manufacture of device 100, multiple known displacements 924 between one or more structural features of kit 312 (e.g., first portion 328, second portion 332, curved end wall 336, and / or recesses 340a, 340b) (hereinafter referred to as "structural features") and window 324 are measured, and data indicating the known displacements 924 are stored in controller memory. For clarity, only one of the known displacements 922 and only one of the known displacements 924 are labeled with reference numerals. Figure 16 As shown, each known displacement 922 and known displacement 924 can be an ordered pair with a vertical x (e.g., horizontal) component and a y (e.g., vertical) component.

[0075] In some embodiments, the processor 212 running the software application 228 of the device 100 can use one or more of the symbols 916, luminescent materials 918, colored regions 920, and structural features as an indicator for determining the location of the read region of the cartridge 312. In such embodiments, the step of analyzing pixels within the one or more images of the cartridge 312 (step 804) can include the processor 212 analyzing the pixels within the one or more images to determine the location of the indicator (i.e., the symbols 916, luminescent materials 918, colored regions 920, or structural features) within the one or more images.

[0076] Determining the location of the symbols 916 or colored regions 920 can include performing one or more image processing-based algorithms, analyses, or operations. Non-limiting examples of the one or more image processing-based algorithms, analyses, or operations include optical character recognition algorithms, Hough transforms, connected component analyses, or machine learning or deep learning models trained on a dataset composed of images of the cartridge 312.

[0077] Determining the location of the luminescent materials 918 can include the processor 212 actuating the light source 204 to illuminate the luminescent materials 918 with a particular wavelength of the electromagnetic spectrum and actuating the sensor 206 to capture one or more images such that the luminescent materials 918 appear different.

[0078] In some embodiments, the processor 212 of the device 100 can be configured to analyze the one or more images to identify one or more of the structural features as an indicator, rather than using the symbols 916, luminescent materials 918, or colored regions 920 as an indicator.

[0079] In embodiments where one or more of the symbols 916 are used as an indicator, the step of determining the read region location of the read region of the liquid sample carrier (step 808) can also be defined as analyzing the pixels within the one or more images to determine the read region location of the read region, where the read region is the window 324, by applying the known displacement 922 to the determined location of the symbols 916 (i.e., adding).

[0080] In embodiments where one or more of the luminescent materials 918 and / or colored regions 920 are used as an indicator, the step of determining the read region location of the read region of the liquid sample carrier (step 808) can also be defined as analyzing the pixels within the one or more images to determine the read region location of the read region, where the read region is the window 324, by identifying the region surrounded by the luminescent materials 918 and / or colored regions 920.

[0081] In embodiments where one or more of the structural features are used as indicators, the step of determining a read area location of a read area of a liquid sample carrier (step 808) can also be defined as analyzing pixels within the one or more images to determine a read area location of the read area, where the read area is the window 324, by applying the known displacement 924 to the determined location of the structural feature (i.e., adding).

[0082] It will be apparent to those skilled in the art that various modifications and variations can be made in the present inventive concept without departing from the spirit or scope of the disclosure. Thus, it is intended that the present inventive concept cover the modifications and variations of this application provided they come within the scope of the appended claims and their equivalents.

[0083] Non-limiting illustrative embodiments The following is a numbered list of non-limiting illustrative embodiments of the inventive concept disclosed herein: Illustrative Embodiment 1. A method comprising: analyzing, by a processor, pixels within an image of a liquid sample carrier to determine a location of an indicator within the image, the liquid sample carrier having a liquid sample disposed thereon; determining, by the processor, a read area location of a read area of the liquid sample carrier within the image based at least in part on the location of the indicator determined by analyzing the pixels within the image; and analyzing, by the processor, pixels within the image depicting the read area to determine a presence and / or absence of a predetermined analyte in the liquid sample.

[0084] Illustrative Embodiment 2. The method of illustrative embodiment 1, wherein analyzing the pixels within the image to determine the location of the indicator within the image is further defined as analyzing the pixels within the image to determine the location of the indicator within the image, wherein the indicator is separate from the liquid sample carrier.

[0085] Illustrative Embodiment 3. The method of any one of illustrative embodiments 1-2, wherein analyzing the pixels within the image to determine the location of the indicator within the image is further defined as analyzing the pixels within the image to determine the location of the indicator within the image, wherein the indicator is disposed on a surface of the liquid sample carrier.

[0086] Illustrative Embodiment 4. The method of any of Illustrative Embodiments 1-3, wherein analyzing the pixels within the image to determine the position of the indicator within the image comprises calculating, by the processor, a one-dimensional gradient representation of the image, and scanning, by the processor, the one-dimensional gradient representation of the image along a predetermined direction to determine a first local maximum / minimum position of a first local maximum / minimum of the one-dimensional gradient representation of the image, wherein the position of the indicator is determined by the first local maximum / minimum position.

[0087] Illustrative Embodiment 5. The method of any of Illustrative Embodiments 1-4, wherein determining a read region position of a read region of the liquid sample carrier within the image is further defined as analyzing, by the processor, the pixels within the image to determine a plurality of read region positions of a plurality of read regions of the liquid sample carrier.

[0088] Illustrative Embodiment 6. The method of any of the preceding Illustrative Embodiments, wherein determining the plurality of read region positions of the plurality of read regions is further defined as determining, by the processor, the plurality of read region positions based at least in part on a plurality of known displacements between the position of the indicator and each of the plurality of read region positions.

[0089] Illustrative Embodiment 7. The method of any of the preceding Illustrative Embodiments, wherein determining the plurality of read region positions of the plurality of read regions is further defined as determining, by the processor, a plurality of additional local maximum / minimum positions of a plurality of additional local maximum / minimum of the one-dimensional gradient representation, wherein each of the plurality of read region positions is determined based on a respective one of the plurality of additional local maximum / minimum positions.

[0090] Illustrative Embodiment 8. The method of any of the preceding Illustrative Embodiments, wherein determining the plurality of read region positions of the plurality of read regions is further defined as determining, by the processor, a second local maximum / minimum position of a second local maximum / minimum of the one-dimensional gradient representation, wherein a first read region position of a first read region is determined based on the second local maximum / minimum position, and a plurality of additional read region positions of a plurality of additional read regions are determined, by the processor, based at least in part on a plurality of known displacements between the first read region position and each of the plurality of additional read region positions.

[0091] Illustrative Embodiment 9. The method of any of the preceding illustrative embodiments, wherein the indicator is one or more symbols disposed on the surface of the liquid sample carrier, and determining the location of the indicator is further defined as performing, by the processor, optical character recognition on the image to detect one or more symbol locations of the one or more symbols, wherein the location of the indicator is determined from the one or more symbol locations.

[0092] Illustrative Embodiment 10. The method of any of the preceding illustrative embodiments, wherein the indicator is one or more colored regions disposed on the surface of the liquid sample carrier, the colored regions having a predetermined color value, and determining the location of the indicator is further defined as detecting, by the processor, the predetermined color value in pixels within the image.

[0093] Illustrative Embodiment 11. The method of any of the preceding illustrative embodiments, wherein the indicator is a material configured to appear light or dark when exposed to a particular wavelength of the electromagnetic spectrum, and determining the location of the indicator is further defined as illuminating, by the processor, the liquid sample carrier with the particular wavelength of the electromagnetic spectrum, and determining, by the processor, the location of the indicator based at least in part on an appearance of the indicator when illuminated with the particular wavelength of the electromagnetic spectrum.

[0094] Illustrative Embodiment 12. An optical inspection apparatus comprising: a housing having an interior containing an inspection location; an indicator located within the inspection location; a light source configured to illuminate the inspection location within the housing; a tray assembly configured to receive a liquid sample carrier, the tray assembly being insertable into the inspection location of the housing; a sensor configured to capture an image of the inspection location of the housing including the indicator; and a controller having a processor operable to execute processor executable code that, when executed by the processor, causes the processor to: analyze pixels within the image captured by the sensor to determine a location of the indicator within the image; determine a read region location of a read region within the image based at least in part on the location of the indicator determined by analyzing the pixels within the image; and analyze pixels within the read region of the image to determine a presence and / or absence of a predetermined analyte.

[0095] Illustrative Embodiment 13. The optical inspection apparatus of any of the preceding illustrative embodiments, wherein the indicator is on the tray assembly.

[0096] Illustrative Embodiment 14. The optical inspection apparatus of any of the preceding illustrative embodiments, wherein the indicator is not on the tray assembly.

[0097] Illustrative Embodiment 15. The optical inspection apparatus of any of the preceding illustrative embodiments, wherein analyzing the pixels within the image to determine a position of the indicator within the image comprises: computing a one-dimensional gradient representation of the image, and scanning the one-dimensional gradient representation of the image along a predetermined direction to determine a first local maximum / minimum position of a first local maximum / minimum of the one-dimensional gradient representation of the image, wherein the position of the indicator is determined by the first local maximum / minimum position.

[0098] Illustrative Embodiment 16. The optical inspection apparatus of any of the preceding illustrative embodiments, wherein determining a read area position of a read area of the liquid sample carrier within the image is further defined as analyzing pixels within the image at a predetermined distance and direction away from the position of the indicator.

[0099] Illustrative Embodiment 17. The optical inspection apparatus of any of the preceding illustrative embodiments, wherein determining the read area position is further defined as determining a plurality of read area positions of a plurality of read areas by analyzing pixels at a plurality of known displacements from the position of the indicator and each of the plurality of read area positions.

[0100] Illustrative Embodiment 18. The optical inspection apparatus of any of the preceding illustrative embodiments, wherein determining the plurality of read area positions of the plurality of read areas is further defined as determining a plurality of additional local maximum / minimum positions of a plurality of additional local maximum / minimum of the one-dimensional gradient representation, wherein each of the plurality of read area positions is determined based on a respective one of the plurality of additional local maximum / minimum positions.

[0101] Illustrative Embodiment 19. The optical inspection apparatus of any of the preceding illustrative embodiments, wherein determining a read area position of a read area within the image is further defined as determining a plurality of read area positions of a plurality of read areas within the image, wherein determining the plurality of read area positions of the plurality of read areas within the image comprises: determining a second local maximum / minimum position of a second local maximum / minimum of the one-dimensional gradient representation, wherein a first read area position of a first read area is determined based on the second local maximum / minimum position, and a plurality of additional read area positions of a plurality of additional read areas is determined by the processor based at least in part on a plurality of known displacements between the first read area position and each of the plurality of additional read area positions.

[0102] Illustrative Embodiment 20. An optical inspection apparatus comprising: a housing having an interior containing an inspection location; a liquid sample carrier having an indicator; a light source configured to illuminate the inspection location within the housing; a tray assembly to receive the liquid sample carrier, the tray assembly being insertable into the inspection location of the housing; a sensor configured to capture an image of the inspection location of the housing including the indicator; and a controller having a processor operable to execute processor executable code that, when executed by the processor, causes the processor to: analyze pixels within the image captured by the sensor to determine a location of the indicator within the image; determine a read region location of a read region within the image based at least in part on the location of the indicator determined by analyzing the pixels within the image; and analyze pixels within the read region of the image to determine a presence and / or absence of a predetermined analyte.

[0103] Illustrative Embodiment 21. The optical inspection apparatus of any of the preceding illustrative embodiments, wherein the liquid sample carrier has a surface, and wherein the indicator is one or more symbols disposed on the surface of the liquid sample carrier, and determining the location of the indicator is further defined as performing optical character recognition of the image to detect one or more symbol locations of the one or more symbols, wherein the location of the indicator is determined by the one or more symbol locations.

[0104] Illustrative Embodiment 22. The optical inspection apparatus of any of the preceding illustrative embodiments, wherein the liquid sample carrier has a surface, and wherein the indicator is one or more colored regions disposed on the surface of the liquid sample carrier, the colored regions having a predetermined color value, wherein the location of the indicator is determined based at least in part on detecting the predetermined color value in the pixels within the image.

[0105] Illustrative Embodiment 23. The optical inspection apparatus of any of the preceding illustrative embodiments, wherein the liquid sample carrier has a surface, and wherein the indicator is a material on the surface of the liquid sample carrier and configured to appear light or dark when exposed to a particular wavelength of the electromagnetic spectrum, and determining the location of the indicator is further defined as illuminating the liquid sample carrier with the particular wavelength of the electromagnetic spectrum by the light source, wherein the location of the indicator is determined based at least in part on an appearance of the indicator when illuminated with the particular wavelength of the electromagnetic spectrum.

Claims

1. A method comprising: The processor analyzes pixels within an image of a liquid sample carrier to determine the location of an indicator within the image, the liquid sample carrier having a liquid sample disposed thereon; The processor determines the location of the reading region of the liquid sample carrier within the image based at least in part on the location of the indicator determined by analyzing the pixels within the image; as well as The processor analyzes the pixels within the image that depict the reading region to determine the presence and / or absence of a predetermined analyte in the liquid sample.

2. The method according to claim 1, wherein, Analyzing the pixels within the image to determine the location of the indicator within the image is further defined as analyzing the pixels within the image to determine the location of the indicator within the image, wherein the indicator is separate from the liquid sample carrier.

3. The method according to claim 1, wherein, Analyzing the pixels within the image to determine the position of the indicator within the image is further defined as analyzing the pixels within the image to determine the position of the indicator within the image, wherein the indicator is disposed on the surface of the liquid sample carrier.

4. The method according to claim 1, wherein, Analyzing pixels within the image to determine the position of the indicator within the image includes: calculating a one-dimensional gradient representation of the image by the processor, and scanning the one-dimensional gradient representation of the image along a predetermined direction by the processor to determine the position of a first local maximum / minimum of a first local maximum / minimum of the one-dimensional gradient representation of the image, wherein the position of the indicator is determined by the position of the first local maximum / minimum.

5. The method according to claim 4, wherein, Determining the reading region location of the liquid sample carrier within the image is further defined by analyzing pixels within the image using the processor to determine multiple reading region locations of multiple reading regions of the liquid sample carrier.

6. The method according to claim 5, wherein, Determining the locations of the plurality of read regions is further defined as determining the locations of the plurality of read regions by the processor based at least in part on a plurality of known displacements between the location of the indicator and each of the plurality of read region locations.

7. The method according to claim 5, wherein, The determination of the plurality of read region locations is further defined by the processor determining the locations of the plurality of additional local maximum / minimum values ​​of the plurality of additional local maximum / minimum values ​​represented by the one-dimensional gradient, wherein each of the plurality of read region locations is determined based on a corresponding one of the plurality of additional local maximum / minimum values.

8. The method according to claim 5, wherein, Determining the multiple read region positions of the multiple read regions is further defined as determining the second local maximum / minimum position of the second local maximum / minimum value of the one-dimensional gradient representation by the processor, wherein the first read region position of the first read region is determined based on the second local maximum / minimum position, and the multiple additional read region positions of the multiple additional read regions are determined by the processor based at least in part on multiple known displacements and directions between the first read region position and each of the multiple additional read region positions.

9. The method according to claim 3, wherein, The indicator is one or more symbols disposed on the surface of the liquid sample carrier, and determining the position of the indicator is further defined by performing optical character recognition of the image by the processor to detect one or more symbol positions of the one or more symbols, wherein the position of the indicator is determined by the one or more symbol positions.

10. The method according to claim 3, wherein, The indicator is one or more colored areas disposed on the surface of the liquid sample carrier, the colored areas having predetermined color values, and determining the position of the indicator is further defined as detecting the predetermined color values ​​in pixels within the image by the processor.

11. The method according to claim 3, wherein, The indicator is a material configured to appear different when exposed to a specific wavelength of electromagnetic spectrum, and determining the location of the indicator is further defined by the processor irradiating the liquid sample carrier with the specific wavelength of electromagnetic spectrum, and by the processor determining the location of the indicator based at least in part on the appearance of the indicator when irradiated with the specific wavelength of electromagnetic spectrum.

12. The method according to claim 1, wherein, Determining the location of the indicator within the image is further defined as using a template gradient stored in a non-transitory memory to confirm the location of the indicator.

13. The method according to claim 12, wherein, Using the template gradient to confirm the position of the indicator is further defined as calculating a correlation factor between the determined position of the indicator in the image and the template gradient, and also includes issuing an alarm when the correlation factor is less than a predetermined threshold.

14. An optical inspection device, comprising: A housing having an interior containing inspection locations; Indicator located within the inspection position; A light source configured to illuminate the inspection location within the housing; A tray assembly configured to receive a liquid sample carrier, the tray assembly being insertable into the inspection position of the housing; A sensor configured to capture an image of the inspection location of the housing, including the indicator; as well as A controller having a processor operable to execute processor-executable code, which, when executed by the processor, causes the processor to: Analyze the pixels within the image captured by the sensor to determine the location of the indicator within the image; The location of the reading region within the image is determined at least in part based on the position of the indicator determined by analyzing the pixels within the image; as well as Analyze the pixels within the reading area of ​​the image to determine the presence and / or absence of a predetermined analyte.

15. The optical inspection apparatus according to claim 14, wherein, The indicator is located on the tray assembly.

16. The optical inspection apparatus according to claim 14, wherein, The indicator is not located on the tray assembly.

17. The optical inspection apparatus according to claim 14, wherein, Analyzing pixels within the image to determine the position of the indicator within the image includes: calculating a one-dimensional gradient representation of the image and scanning the one-dimensional gradient representation of the image along a predetermined direction to determine the position of a first local maximum / minimum of a first local maximum / minimum of the one-dimensional gradient representation of the image, wherein the position of the indicator is determined by the position of the first local maximum / minimum.

18. The optical inspection apparatus according to claim 17, wherein, The location of the reading area of ​​the liquid sample carrier within the image is further defined as analyzing pixels within the image that are located at a predetermined distance and direction away from the indicator.

19. The optical inspection apparatus according to claim 18, wherein, Determining the read area location is further defined as determining multiple read area locations of a plurality of read areas, which is achieved by analyzing pixels at multiple known displacements of each of the plurality of read area locations, based on the distance from the indicator.

20. The optical inspection apparatus according to claim 19, wherein, Determining the multiple read region positions is further defined as determining multiple additional local maximum / minimum positions of multiple additional local maximum / minimum values ​​of the one-dimensional gradient representation, wherein each of the multiple read region positions is determined based on a corresponding one of the multiple additional local maximum / minimum positions.

21. The optical inspection apparatus according to claim 17, wherein, Determining the readout region position within the image is further defined as determining multiple readout region positions within the image, wherein determining the multiple readout region positions within the image includes: determining the second local maximum / minimum position of the second local maximum / minimum value of the one-dimensional gradient representation, wherein the first readout region position of the first readout region is determined based on the second local maximum / minimum position, and the multiple additional readout region positions of the multiple additional readout regions are determined by the processor based at least in part on multiple known displacements and directions between the first readout region position and each of the multiple additional readout region positions.

22. The optical inspection apparatus according to claim 14, wherein, Determining the location of the indicator within the image is further defined as using a template gradient stored in a non-transitory memory to confirm the location of the indicator.

23. The method according to claim 22, wherein, Using the template gradient to confirm the position of the indicator is further defined as calculating a correlation factor between the determined position of the indicator in the image and the template gradient, and also includes issuing an alarm when the correlation factor is less than a predetermined threshold.

24. An optical inspection device, comprising: A housing having an interior containing inspection locations; Liquid sample carrier with indicator; A light source configured to illuminate the inspection location within the housing; A tray assembly for receiving the liquid sample carrier, the tray assembly being insertable into the inspection position of the housing; A sensor configured to capture an image of the inspection location of the housing, including the indicator; as well as A controller having a processor operable to execute processor-executable code, which, when executed by the processor, causes the processor to: Analyze the pixels within the image captured by the sensor to determine the location of the indicator within the image; The location of the reading region within the image is determined at least in part based on the position of the indicator determined by analyzing the pixels within the image; as well as Analyze the pixels within the reading area of ​​the image to determine the presence and / or absence of a predetermined analyte.

25. The optical inspection apparatus according to claim 24, wherein, The liquid sample carrier has a surface, and wherein the indicator is one or more symbols disposed on the surface of the liquid sample carrier, and determining the position of the indicator is further defined as performing optical character recognition of the image to detect one or more symbol positions of the one or more symbols, wherein the position of the indicator is determined by the one or more symbol positions.

26. The optical inspection apparatus according to claim 24, wherein, The liquid sample carrier has a surface, and the indicator is one or more colored regions disposed on the surface of the liquid sample carrier, the colored regions having predetermined color values, wherein the position of the indicator is determined at least in part based on detecting the predetermined color values ​​in pixels within the image.

27. The optical inspection apparatus according to claim 24, wherein, The liquid sample carrier has a surface, and wherein the indicator is a material located on the surface of the liquid sample carrier and configured to appear different when exposed to an electromagnetic spectrum of a specific wavelength, and determining the position of the indicator is further defined as irradiating the liquid sample carrier with the electromagnetic spectrum of the specific wavelength by the light source, wherein the position of the indicator is determined at least in part based on the appearance of the indicator when irradiated with the electromagnetic spectrum of the specific wavelength.

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